On Monday, Alembic Pharmaceuticals said it had received regulatory approval from the US Food and Drug Administration (USFDA) for chlorthalidone tablets used to treat high blood pressure. The company has received final approval from the US health regulator for marketing the product in the US in 25 mg and 50 mg doses.

Alembic’s chlorthalidone drug is therapeutically equivalent to Hygroton tablets of Sanofi Aventis. Chlorthalidone, a type of Diuretic, is primarily used to manage hypertension. It is either used as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs. Chlorthalidone is also used in adjunctive therapy in edema associated with hepatic cirrhosis, congestive heart failure, corticosteroid, and estrogen therapy.

Reportedly, the product has also been found helpful in treating edema because of various forms of renal dysfunction caused by nephrotic syndrome, chronic renal failure, and acute glomerulonephritis. According to the global provider of advanced analytics IQVIA, chlorthalidone tablets have an estimated market size of USD 37 million.

Headquartered in Vadodara, Alembic Pharmaceuticals Ltd. is a multinational pharmaceutical company engaged in manufacturing pharmaceutical products. Founded in 1907, it has become a market leader in India’s macrolides segment of anti-infective drugs.